FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8113–8136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2024
Hem-o-lok® Ligating Clips
K232970 · FZP
Teleflex Medical
General & Plastic Surgery · 113d
Cleared Jan 12, 2024
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape))
K232615 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 137d
Cleared Jan 12, 2024
Ti Link Abutment
K232170 · NHA
Izenimplant Co., Ltd.
Dental · 175d
Cleared Jan 12, 2024
PROBEAT-FR
K232032 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 189d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
K231970 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 12, 2024
SoloSmart Injection Pen Adapter (SoloSmart®)
K231820 · QOG
Biocorp Production
General Hospital · 205d
Cleared Jan 12, 2024
Quick - Radius Disposable Set
K231684 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 217d
Cleared Jan 12, 2024
SMB Luer lock disposable syringe
K231558 · FMF
Smb Corporation of India
General Hospital · 227d
Cleared Jan 12, 2024
BEE Cervical Cage
K231371 · ODP
NGMedical GmbH
Orthopedic · 245d
Cleared Jan 12, 2024
Velox Power Chair
K231315 · ITI
Velox Manufacturing, Inc.
Physical Medicine · 252d
Cleared Jan 12, 2024
MD Mattress Suture Placement Device
K222783 · GCJ
Lsi Solutions, Inc.
General & Plastic Surgery · 484d
Cleared Jan 11, 2024
ProxiDiagnost N90 / Precision CRF (706110, 706400)
K233945 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Jan 11, 2024
PRIMA Humeral System
K233712 · MBF
Lima Corporate S.P.A.
Orthopedic · 52d
Cleared Jan 11, 2024
IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06...
K233664 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 57d
Cleared Jan 11, 2024
Clevaligner Software (V1.0.0)
K233616 · PNN
Clevaligner, Ltd.
Dental · 59d
Cleared Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode...
K232995 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 111d
Cleared Jan 11, 2024
U-Lite PRO
K232285 · IYN
Sonoscanner Sarl
Radiology · 164d
Cleared Jan 11, 2024
SurgiCount+ System
K232250 · PBZ
Stryker Instruments
General & Plastic Surgery · 167d
Cleared Jan 11, 2024
CoralView® Single-use Digital Flexible Ureteroscope (U10)
K231774 · FGB
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 209d
Cleared Jan 11, 2024
Disposable Hemoclip (AF series)
K231633 · PKL
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 220d
Cleared Jan 11, 2024
Copper Foam Dressing (Prescription and OTC)
K231088 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 269d
Cleared Jan 11, 2024
ToxiSeal Vial Adapter with External Balloon
K222929 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 472d
Cleared Jan 10, 2024
CarboClear® X Pedicle Screw System
K233944 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 27d
Cleared Jan 10, 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903 · HAW
Zeta Surgical, Inc.
Neurology · 30d